Computer System Validation

GMP data exist in paper or electronic form, with the latter becoming more and more common. The reasons are obvious: due to the increasing amounts of data, a reasonable evaluation on paper is becoming increasingly difficult. In addition, all the compliance requirements, once set up, are much easier to handle in electronic form and with fewer staff. You just have to set it up once. And in this webinar you will learn how this can be done in a lean and simple way.

Detailed requirements for process validation (Part 3 - Process Validation and Site Transfer)

Process validations are no longer seen as an isolated process at the end of development or after "site transfers". Today, they are expected to be embedded in a life cycle concept and to comply with QRM principles. With the webinar series, that we have recorded, we give an overview of the recent requirements in this context. The individual webinar parts build on each other. You can stop the recording at any time and thus also view it separately by part.

Regulatory requirements for import and distribute medicinal cannabis in Europe and Germany in particular

The regulatory framework for the import of medicinal cannabis and its distribution to patients in the EU member states not harmonised at all and there are distinct national regulations. The first part of the webinar has a focus on general requirements in place applicable in all EU member states and the specific requirements in Germany.  Regarding the quality of such products, the general requirements for herbal medicinal products as defined in the European Pharmacopoeia, national pharmacopoeias and the EMA guidance documents in place beside GMP requirements in the EU are applicable. The second webinar has a focus on quality requirements applicable in Europe and Germany.

Post validation activities | Site Transfers (Part 4 - Process Validation and Site Transfer)

Process validations are no longer seen as an isolated process at the end of development or after "site transfers". Today, they are expected to be embedded in a life cycle concept and to comply with QRM principles. With the webinar series, that we have recorded, we give an overview of the recent requirements in this context. The individual webinar parts build on each other. You can stop the recording at any time and thus also view it separately by part.

Development and Validation of Analytical Procedures for Small Molecules | Module 1: Regulatory Requirements & Guidance Documents

Background: The development of appropriate analytical procedures and their validation, if applicable with subsequent transfer to routine laboratories, is one of the essential prerequisites for pharmaceutical quality control of active substances and medicinal products as well as drug-related products such as food supplements and medical devices. The intensive training covers all aspects to be considered for the analysis of small molecules. The focus is not only on the regulatory requirements (US, Europe, ANVISA, ICH, WHO), but rather on their practical implementation. A special focus is on current developments such as life cycle concepts and the new requirements for analytical validation in the US USP. Most of the aspects will be covered using HPLC as exemplarily testing p

Development and Validation of Analytical Procedures for Small Molecules | Compact Training | English

Background: The development of appropriate analytical procedures and their validation, if applicable with subsequent transfer to routine laboratories, is one of the essential prerequisites for pharmaceutical quality control of active substances and medicinal products as well as drug-related products such as food supplements and medical devices. The training covers all main aspects to be considered for the analysis of small molecules. The focus is not only on the regulatory requirements, but rather on their practical implementation. A special focus is on current developments such as life cycle concepts and the new requirements for analytical validation in the US USP. Most of the aspects will be covered using HPLC as exemplarily testing procedure.

Development and Validation of Analytical Procedures for Small Molecules | Online intensive training | 7 part-series in 4 modules

Background: The development of appropriate analytical procedures and their validation, if applicable with subsequent transfer to routine laboratories, is one of the essential prerequisites for pharmaceutical quality control of active substances and medicinal products as well as drug-related products such as food supplements and medical devices. The intensive training covers all aspects to be considered for the analysis of small molecules. The focus is not only on the regulatory requirements (US, Europe, ANVISA, ICH, WHO), but rather on their practical implementation. A special focus is on current developments such as life cycle concepts and the new requirements for analytical validation in the US USP. Most of the aspects will be covered using HPLC as exemplarily testing p

Quality, GMP and GACP Requirements for Medicinal Cannabis and Cannabis Products in the EU and Switzerland – Part 2

Medicinal cannabis and respective products have been available in EU member states as single-patient prescriptions without regular marketing authorisations for a couple of years. The Netherlands was the first member state to realise this, in the meantime other member states have followed. Today, beside the Netherlands, Germany is the most important market for such products. The regulatory framework for the approval of medicinal cannabis and its distribution to patients in the EU member states is, however, not harmonised at all and there are distinct national regulations. Regarding the quality of such products, the general requirements for herbal medicinal products as defined in the European Pharmacopoeia, national pharmacopoeias and the EMA guidance documents in place beside GMP r

GACP Audits for Herbal Medicinal Products

Annex 7 of the EU GMP guideline clearly states that the cultivation, harvesting and processing of herbal starting material must be carried out under GACP as early as the authorisation stage, but also throughout the entire life cycle of GMP-compliant manufacturing of herbal medicinal products. This must be proven by means of a GACP declaration by the applicant and later by the marketing authorisation holder. The initial inspection and further monitoring always require audits. 

The transitions between the requirements for starting materials and active substances are fluid in the case of herbal medicinal products and depend on the processing and manufacture of the respective plants - and therefore your existing or planned manufacturing process is decisi

Vaporiser and other medical devices for Medicinal Cannabis, the CE-marked Device

The general safety and performance requirements for EU CE marking are defined in Annex I of the Medical Device Regulation (EU) 2017/745 (MDR). For these products, a conformity assessment procedure is to be carried out and a certification body (Notified Body) is to be involved. This applies to all vaporisers but might be different for other medical devices, depending on the potential risk of the device. For this purpose, the MDR provides for a differentiation of the devices into 4 main classes (I, IIa, IIb, III). This classification is based on the criteria laid down in Annex VIII of the MDR. Vaporisers of medicinal products are categorised as IIb (rule 20 of Annex VIII of MDR and related explanation in MDCG 2021-24 "Guidance on classification of medical devices&a

Quality, GMP and GACP Requirements for Medicinal Cannabis and Cannabis Products in the EU and Switzerland – Status Quo (2 part-series |4h content)

Medicinal cannabis and respective products have been available in EU member states as single-patient prescriptions without regular marketing authorisations for a couple of years. The Netherlands was the first member state to realise this, in the meantime other member states have followed. Today, beside the Netherlands, Germany is the most important market for such products. The regulatory framework for the approval of medicinal cannabis and its distribution to patients in the EU member states is, however, not harmonised at all and there are distinct national regulations. Regarding the quality of such products, the general requirements for herbal medicinal products as defined in the European Pharmacopoeia, national pharmacopoeias and the EMA guidance documents in place beside GMP r

Validation of pharmaceutical packaging (Part 5 - Process Validation and Site Transfer)

Process validations are no longer seen as an isolated process at the end of development or after "site transfers". Today, they are expected to be embedded in a life cycle concept and to comply with QRM principles. With the webinar series, that we have recorded, we give an overview of the recent requirements in this context. The individual webinar parts build on each other. You can stop the recording at any time and thus also view it separately by part.

Development and Validation of Analytical Procedures for Small Molecules | Module 2: Basic requirements and validation prameters

Background: The development of appropriate analytical procedures and their validation, if applicable with subsequent transfer to routine laboratories, is one of the essential prerequisites for pharmaceutical quality control of active substances and medicinal products as well as drug-related products such as food supplements and medical devices. The intensive training covers all aspects to be considered for the analysis of small molecules. The focus is not only on the regulatory requirements (US, Europe, ANVISA, ICH, WHO), but rather on their practical implementation. A special focus is on current developments such as life cycle concepts and the new requirements for analytical validation in the US USP. Most of the aspects will be covered using HPLC as exemplarily testing p

GACP Audits for Herbal Medicinal Products (2 part-series: GACP basics and case studies in demarcation and auditing)

Annex 7 of the EU GMP guideline clearly states that the cultivation, harvesting and processing of herbal starting material must be carried out under GACP as early as the authorisation stage, but also throughout the entire life cycle of GMP-compliant manufacturing of herbal medicinal products. This must be proven by means of a GACP declaration by the applicant and later by the marketing authorisation holder. The initial inspection and further monitoring always require audits. 

The transitions between the requirements for starting materials and active substances are fluid in the case of herbal medicinal products and depend on the processing and manufacture of the respective plants - and therefore your existing or planned manufacturing process is decisi

Quality, GMP and GACP Requirements for Medicinal Cannabis and Cannabis Products in the EU and Switzerland - Part 1

Medicinal cannabis and respective products have been available in EU member states as single-patient prescriptions without regular marketing authorisations for a couple of years. The Netherlands was the first member state to realise this, in the meantime other member states have followed. Today, beside the Netherlands, Germany is the most important market for such products. The regulatory framework for the approval of medicinal cannabis and its distribution to patients in the EU member states is, however, not harmonised at all and there are distinct national regulations. Regarding the quality of such products, the general requirements for herbal medicinal products as defined in the European Pharmacopoeia, national pharmacopoeias and the EMA guidance documents in place beside GMP r

The general chapters and monographs in the European Pharmacopeia revisited

The general chapters and general monographs in the European Pharmacopeia provide a framework, which is legally binding in 39 member states. Important general chapters and general monographs underwent recently major revision, new general monographs have been added. In January 2023 the 11. Edition of the European Pharmacopoeia became official. A good opportunity to revisit these chapters and monographs and to explore changes and added requirements with impact to pharmaceutical quality control and stability testing.

Module 7: GxP Audits – Specific audit requirements: GDP

To complement the more general audit training, we offer some additional modules dedicated to specific aspects/questions and/or hot topics when auditing medicinal cultivation companies (acc. to GACP), manufacturers (acc. to GMP), quality control laboratories (acc. to GMP quality control), and distributors (acc. to GDP).  

GxP Audits – Specific audit requirements: GMP Quality Control & Stability Testing

Specific audit requirements: GMP Quality Control & Stability Testing

• Key aspects of the quality control laboratory. Main areas and layout. 
• In-process and final product quality controls. Acceptance criteria. How to evaluate deviations? 
• Stability studies: Define the protocol, run the study and evaluate the results. How to deal with OOS? 
• Method validation. Key aspects and questions. 
• Real practical situations and/or quiz about module 6.   

Module 1: Potential Impurities | Current developments for organic impurities in small molecule APIs and respective medicinal products

Impurities in small molecule active ingredients, excipients, medicinal products and packaging materials are important attributes in the assessment of quality and safety of medicinal products - this applies to all phases of the product life cycle. Not least the contamination by nitrosamines has changed regulators view of the subject and today we have to deal with the subject more intensively. Impurities are "on the move", applicants and marketing authorization holders need to anticipate potential impurities and to subsequently identify, specify and qualify respective compounds. This applies to projects with new products, but also to specific occasions, such as the renewal of marketing authorisations, the sourcing of new active substances and excipients, changes in

Continuous Manufacturing and GMP Compliance – yes but how?

On 16th November 2022 the International Council for Harmonisation (ICH) published the Q13 guideline for Continuous Manufacturing for APIs and finished product. This guideline expands the draft of the FDA Center for Drug Evaluation and Research (CDER) concerning quality considerations for continuous manufacturing (CM). In this draft the FDA see Continuous Manufacturing as a chance for the industry to improve the experiences with the manufacturing process and to improve the process controls.

The realization of CM referring to equipments and technology is the one side, but how to realize it from the GMP-compliance point of view is the other side. In this course we will have a detailed look into the ICH Q13, as well as into the requirements by the FDA. Examples f

Live cycle concepts and pharmaceutical development as a prerequisite for process validation (Part 2 - Process Validation and Site Transfer)

Process validations are no longer seen as an isolated process at the end of development or after "site transfers". Today, they are expected to be embedded in a life cycle concept and to comply with QRM principles. With the webinar series, that we have recorded, we give an overview of the recent requirements in this context. The individual webinar parts build on each other. You can stop the recording at any time and thus also view it separately by part.

Development and Validation of Analytical Procedures for Small Molecules | Intensive Training | Module 4 | English

Background: The development of appropriate analytical procedures and their validation, if applicable with subsequent transfer to routine laboratories, is one of the essential prerequisites for pharmaceutical quality control of active substances and medicinal products as well as drug-related products such as food supplements and medical devices. The intensive training covers all aspects to be considered for the analysis of small molecules. The focus is not only on the regulatory requirements (US, Europe, ANVISA, ICH, WHO), but rather on their practical implementation. A special focus is on current developments such as life cycle concepts and the new requirements for analytical validation in the US USP. Most of the aspects will be covered using HPLC as exemplarily testing p

Regulatory Requirements & Guidance Documents (Part 1 - Process Validation and Site Transfer)

Process validations are no longer seen as an isolated process at the end of development or after "site transfers". Today, they are expected to be embedded in a life cycle concept and to comply with QRM principles. With the webinar series, that we have recorded, we give an overview of the recent requirements in this context. The individual webinar parts build on each other. You can stop the recording at any time and thus also view it separately by part.

Current developments for organic impurities in small molecule APIs and respective medicinal products

Impurities in small molecule active ingredients, excipients, medicinal products and packaging materials are important attributes in the assessment of quality and safety of medicinal products - this applies to all phases of the product life cycle. Not least the contamination by nitrosamines has changed regulators view of the subject and today we have to deal with the subject more intensively. Impurities are "on the move", applicants and marketing authorization holders need to anticipate potential impurities and to subsequently identify, specify and qualify respective compounds. This applies to projects with new products, but also to specific occasions, such as the renewal of marketing authorisations, the sourcing of new active substances and excipients, changes in

Development and Validation of Analytical Procedures for Small Molecules | Module 3: Analytical procedure Development and Prevalidation-Life cycle Management of analytical procedures | Englisch

Background: The development of appropriate analytical procedures and their validation, if applicable with subsequent transfer to routine laboratories, is one of the essential prerequisites for pharmaceutical quality control of active substances and medicinal products as well as drug-related products such as food supplements and medical devices. The intensive training covers all aspects to be considered for the analysis of small molecules. The focus is not only on the regulatory requirements (US, Europe, ANVISA, ICH, WHO), but rather on their practical implementation. A special focus is on current developments such as life cycle concepts and the new requirements for analytical validation in the US USP. Most of the aspects will be covered using HPLC as exemplarily testing p

Module 2: Genotoxic impurities | Current developments for organic impurities in small molecule APIs and respective medicinal products

Impurities in small molecule active ingredients, excipients, medicinal products and packaging materials are important attributes in the assessment of quality and safety of medicinal products - this applies to all phases of the product life cycle. Not least the contamination by nitrosamines has changed regulators view of the subject and today we have to deal with the subject more intensively. Impurities are "on the move", applicants and marketing authorization holders need to anticipate potential impurities and to subsequently identify, specify and qualify respective compounds. This applies to projects with new products, but also to specific occasions, such as the renewal of marketing authorisations, the sourcing of new active substances and excipients, changes in